Open-label, long-term safety study of zonisamide administered to children and adolescents with epilepsy

Shlomo Shinnar, John M. Pellock, Joan A. Conry

Research output: Contribution to journalArticle

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Abstract

Background: Zonisamide is licensed in the EU and USA for the adjunctive treatment of partial-onset seizures in adults but there are few data about its use in children. Aims: To assess the long-term safety and efficacy of zonisamide in children and adolescents. Methods: Zonisamide-naïve patients (n=109, aged 3-15 years, weight ≥12.5 kg) with a clinical diagnosis of epilepsy (≥4 seizures/month, receiving 1-2 antiepileptic drugs [AEDs] daily) received zonisamide once or twice daily in an open-label trial. The starting dose was 1 mg/kg/day, increased by 2 mg/kg/day every 1-2 weeks at the investigator's discretion to an initial maximum of 12 mg/kg/day. The occurrence of adverse events (AEs) was the primary safety measure. Efficacy was measured via the reductions in seizure frequency and via investigator- and carer-rated global assessment ratings. Results: The mean dose received was 8.5 mg/kg/day. Of the 109 children, 52 (48%) completed 15 months' treatment. Treatment-related AEs, mostly mild-to-moderate in severity, were reported by 58 patients. Seven patients discontinued due to treatment-related AEs. Serious AEs (pancreatitis, decreased sweating, and vertigo) were reported by three patients. A significant (p=0.033) median reduction in 'all seizure' frequency of 2.60 seizures per week was observed. Additionally, a significant (p=0.029) median reduction of 1.80 seizures/week in 'complex partial' seizures was reported. Improvements in investigator- and carer-rated global assessments were noted. Conclusions: Zonisamide treatment was generally well tolerated and was associated with significant reductions in seizure frequency in this pediatric population with a variety of both partial and generalized medically refractory epilepsy syndromes.

Original languageEnglish (US)
Pages (from-to)3-9
Number of pages7
JournalEuropean Journal of Paediatric Neurology
Volume13
Issue number1
DOIs
StatePublished - Jan 2009

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zonisamide
Epilepsy
Seizures
Safety
Research Personnel
Caregivers
Therapeutics
Sweating
Vertigo

Keywords

  • Antiepileptic drugs
  • Epilepsy
  • Pediatric epilepsy
  • Zonisamide

ASJC Scopus subject areas

  • Clinical Neurology
  • Pediatrics, Perinatology, and Child Health

Cite this

Open-label, long-term safety study of zonisamide administered to children and adolescents with epilepsy. / Shinnar, Shlomo; Pellock, John M.; Conry, Joan A.

In: European Journal of Paediatric Neurology, Vol. 13, No. 1, 01.2009, p. 3-9.

Research output: Contribution to journalArticle

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abstract = "Background: Zonisamide is licensed in the EU and USA for the adjunctive treatment of partial-onset seizures in adults but there are few data about its use in children. Aims: To assess the long-term safety and efficacy of zonisamide in children and adolescents. Methods: Zonisamide-na{\"i}ve patients (n=109, aged 3-15 years, weight ≥12.5 kg) with a clinical diagnosis of epilepsy (≥4 seizures/month, receiving 1-2 antiepileptic drugs [AEDs] daily) received zonisamide once or twice daily in an open-label trial. The starting dose was 1 mg/kg/day, increased by 2 mg/kg/day every 1-2 weeks at the investigator's discretion to an initial maximum of 12 mg/kg/day. The occurrence of adverse events (AEs) was the primary safety measure. Efficacy was measured via the reductions in seizure frequency and via investigator- and carer-rated global assessment ratings. Results: The mean dose received was 8.5 mg/kg/day. Of the 109 children, 52 (48{\%}) completed 15 months' treatment. Treatment-related AEs, mostly mild-to-moderate in severity, were reported by 58 patients. Seven patients discontinued due to treatment-related AEs. Serious AEs (pancreatitis, decreased sweating, and vertigo) were reported by three patients. A significant (p=0.033) median reduction in 'all seizure' frequency of 2.60 seizures per week was observed. Additionally, a significant (p=0.029) median reduction of 1.80 seizures/week in 'complex partial' seizures was reported. Improvements in investigator- and carer-rated global assessments were noted. Conclusions: Zonisamide treatment was generally well tolerated and was associated with significant reductions in seizure frequency in this pediatric population with a variety of both partial and generalized medically refractory epilepsy syndromes.",
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